BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EON MINI

    MDR report key: 2843410 · Received November 15, 2012

    Report

    Report Number
    1627487-2012-13089
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 22, 2012
    Report Date
    October 25, 2012
    Manufacturer
    ST. JUDE MEDICAL - NEUROMODULATION
    Product Code
    LGW
    PMA / PMN Number
    P010032
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    SJM HAS LIMITED INFORMATION RELATED TO THE PATIENT'S MEDICAL HISTORY AND IS UNABLE TO FORM AN OPINION AS TO THE RELEVANCY OF THE PATIENT'S HISTORY TO THE EVENT REPORTED. SJM DEFERS TO THE PATIENT'S PHYSICIAN REGARDING MEDICAL HISTORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT WAS NO LONGER RECEIVING STIMULATION AND WAS UNABLE TO COMMUNICATE WITH OR CHARGE HIS IPG. A SJM REPRESENTATIVE MET WITH THE PATIENT AND CONFIRMED THE ISSUE. SURGICAL INTERVENTION IS PENDING TO ADDRESS THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EON MINI SCS IPG LGW ST. JUDE MEDICAL - NEUROMODULATION 3788 3536386

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention IMPLANT DATE:| IMPLANT DATE:| IMPLANT DATE:| SCS EXTENSION, MODEL 3341| IMPLANT DATE:| SCS LEAD, MODEL 3186| SCS ANCHOR, MODEL 1192| SCS LEAD, MODEL 3166 (2)